Sevorane Adverse Reactions

As with all potent inhaled anesthetics, sevoflurane may cause dose-dependent cardiorespiratory depression. Most adverse events are mild or moderate in severity and transient in duration. Nausea and vomiting have been observed in the postoperative period, common sequelae of surgery and general anesthesia, which may be due to inhalational anesthetic, other agents administered intraoperatively or postoperatively, and to the patient's response to the surgical procedure.
Adverse Event Data Derived from Controlled Clinical Trials: The most frequent adverse events (≥10%) considered to be probably related to sevoflurane administration overall were: Nausea, vomiting, increased cough and hypotension.
Adults: Most Frequent Adverse Events (≥10%): Nausea, vomiting and hypotension.
Elderly (≥10%): Hypotension, nausea and bradycardia.
Children (>10%): Vomiting, agitation, increased cough and nausea.
The type, severity, and frequency of adverse events in sevoflurane patients were comparable to adverse events in reference-drug patients.
The most frequent adverse events (>10%) considered to be probably related to sevoflurane administration overall were: Nausea, vomiting, increased cough, hypotension, agitation, somnolence, chills, bradycardia, dizziness, increased salivation, respiratory disorder, hypertension, tachycardia, laryngismus and fever.
Transient elevations in glucose and white blood cell count may occur as with use of other anesthetic agents.
Transient increases in serum inorganic fluoride levels may occur during and after sevoflurane anesthesia. Concentrations of inorganic fluoride generally peak within 2 hrs of the end of sevoflurane anesthesia and return within 48 hrs to preoperative levels. In clinical trials, elevated fluoride concentrations were not associated with impairment of renal functions.
Occasional cases of transient changes in hepatic function tests were reported with sevoflurane and reference agents.
In the Abbott Clinical Program, which included 5560 patients/volunteers, 17 deaths (9 sevoflurane, 8 isoflurane) were reported. All deaths were considered to be of unknown origin or to have no relationship to study drug.
Post-Marketing Experience: Rare reports of postoperative hepatitis exist, but with an uncertain relationship to sevoflurane.
As with other anesthetic agents, cases of dystonic movement with spontaneous resolution have been reported in children receiving sevoflurane for induction of anesthesia, with an uncertain relationship to sevoflurane.
As with other halogenated agents, rare events of malignant hyperthermia have been reported (see Warnings).
Drug Abuse and Dependence: None known.